Codman Disposable Skull Pins
by Codman & Shurtleff, Inc. 510(k)
Active
510(k) K911723
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911723 | Date10 Sep 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HBL
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4460
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Codman Disposable Skull Pins are classified as a Holder, Head, Neurosurgical (Skull Clamp), a device designed to secure the patient’s skull during neurosurgical procedures. These pins provide a stable fixation point to maintain the head and neck in a precise position, facilitating precise surgical access and manipulation. Constructed for single-use, they are intended to minimize contamination risks and ensure patient safety in sterile environments.
These pins are supplied as disposable medical devices, intended for use in neurosurgical settings where sterility is critical. They are regulated under FDA 510(k) clearance (K911723) and fall under the Neurology advisory committee classification. No additional regulatory status beyond the stated FDA_510K authorization is implied. The device is designed for one-time use and must be discarded after use to prevent cross-contamination.
Other devices from Codman & Shurtleff, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of Codman Disposable Skull Pins?
Codman Disposable Skull Pins are designed as a Holder, Head, Neurosurgical (Skull Clamp) to secure a patient’s skull during neurosurgical procedures. They create a stable fixation point, allowing surgeons to maintain precise head and neck positioning for accurate surgical access and manipulation. This stability is critical for minimizing movement and ensuring safety during delicate neurosurgical interventions.
Are Codman Disposable Skull Pins intended for single-use or reuse?
These pins are explicitly designed for single-use only. The manufacturer emphasizes this to prevent cross-contamination and maintain patient safety in sterile environments. After use, the pins must be discarded to comply with infection control protocols and regulatory guidelines.
How are Codman Disposable Skull Pins supplied, and what does this mean for clinical use?
Codman Disposable Skull Pins are supplied as disposable medical devices, meaning they come pre-packaged and ready for immediate use without requiring reprocessing. This ensures sterility and eliminates the need for cleaning or sterilization between procedures, which is particularly important in neurosurgery where maintaining a sterile field is non-negotiable.
What regulatory pathway does Codman Disposable Skull Pins follow?
Codman Disposable Skull Pins are regulated under the FDA’s 510(k) clearance process, specifically with clearance number K911723. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable safety and effectiveness requirements. The device falls under the Neurology advisory committee classification, reflecting its specialized use in neurosurgical procedures.
Are there multiple sizes or models of Codman Disposable Skull Pins?
The provided data lists multiple registration numbers (e.g., 1721676, 3013557562, etc.) under the product code HBL, which may correspond to different sizes or variations of the Codman Disposable Skull Pins. However, the exact specifications for each size or model (e.g., pin diameter, length, or design) are not detailed in the provided information. Clinicians should refer to the manufacturer’s documentation or catalog for precise sizing options to ensure compatibility with their surgical needs.